Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury

Not Applicable

Completed

• Conditions: TMJ Disorder
• Interventions: Other: TMJ physical therapy program; Device: Pulsed Electromagnetic Field therapy (PEMFT)

• Registration Number: NCT04561037
• Lead Sponsor: Kafrelsheikh University

Brief Summary

This study is aiming to investigate the effect of magnetic therapy in combination with traditional physical therapy on the pain and mouth opening, after facial penetrating wound injury with no facial fractures, that treated conservatively

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-20
• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-23
• Primary Completion: 2020-10-02
• Study Completion: 2020-10-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• TMJ pain and mouth opening limitation after 1 month of facial penetrating wound injury as the wound is fully healed.
• TMJ pain (in 1 or both joints) after facial penetrating wound injury.

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Exclusion Criteria

• Patient excluded from the study if they had one of the following:
• TMJ fracture or dislocation
• Previous TMJ surgeries
• Dental diseases
• Infectious or systemic diseases
• Pregnancy
• Malignancy
• Pacemaker or metal implants
• Systemic diseases that affect joint function such as rheumatoid arthritis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	TMJ physical therapy program	Control group patients received traditional physical therapy treatment. The traditional physical therapy treatment program consisted of TMJ mobilization techniques include distraction, anterior glide, anterior glide with pre-positioned mouth opening, medial/lateral glides, caudal-anterior-medial (CAM) glide, and CAM glide with pre-positioned mouth opening and isometric exercises against resistance for muscles of mastication.
Study Group	Pulsed Electromagnetic Field therapy (PEMFT)	Study group patients received PEMFT, using EMG 8400 PEMF device (made in Italy, by EME) in addition to physical therapy treatment program.

Primary Outcome Measures

Name	Time	Method
Change in the Maximum mouth opening in millimeter (mm) before and after intervention.	Change between baseline and 4 weeks of treatment measures.	Each participant was asked to open his or her mouth as wide as possible after that the examiner used a digital Vernier caliper to measure the maximum vertical distance from the incisal edge of the upper central incisors to the incisal edge of the lower central incisors at the midline

Secondary Outcome Measures

Name	Time	Method
Change in TMJ pain measured by Visual Analogue Scale (VAS)	Change between baseline and 4 weeks of treatment measures.	Visual Analogue Scale (VAS) was used to evaluate pain intensity. VAS is a subjective pain measurement method consisting of a straight line of 100 mm on which patients scored their pain intensity where 0 corresponds to no pain and 10 corresponds to the worst maximum pain

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafr El Sheikh, Egypt